Novel Post-surgical Incision Management Device to Prevent Ostomy Complications

项目总结/摘要 在美国（US），由于各种原因，每年有超过100，000名所有年龄段的患者接受造口术手术。 病理生理状况包括结肠直肠癌、炎性肠病（克罗恩病和 溃疡性结肠炎）、肠梗阻、憩室炎和许多其它医学病症。造口手术也可能 在事故或受伤造成严重腹部或骨盆创伤的情况下， 在服兵役期间。作为一种挽救生命的手术，造口术手术允许身体废物通过外科手术 在腹部创造一个称为造口的开口，进入一个称为“口袋”或“造口袋”的假体， 在身体之外。患者在造口创建后几天内出院， 在家里使用一次性造口术袋连接到他们的造口周围的皮肤愈合。不幸的是，目前 袋设计对术后水肿（肿胀）提供很少的治疗益处并且不能保持紧密密封， 从而导致肠液和废物的泄漏。由此产生的造口并发症包括粘膜皮肤 (skin/造口）分离、造口回缩和湿气相关的皮肤损伤。多达70%的造口术患者 忍受这些并发症，其中29%的患者需要再次住院，额外费用为 每个病人78,000美元此外，高体重指数（BMI）患者的并发症风险更高。 考虑到需要造口术手术的临床状况的增加，美国人口的BMI增加， 目前的报销格局，惩罚医疗保健系统的再入院，一个改善后， 迫切需要防止造口术并发症外科切口处理装置。在此SBIR Direct 第二阶段，瘘管解决方案将开发一种新型的术后造口术切口管理装置， 防止并发症，形成紧密密封，并保护新造口。这个装置稳定了周围的组织 造口，以减少水肿和缝线张力，沿着将皮肤/造口连接处保持在一起，以便于 治愈此外，该装置还可形成牢固的密封，以阻止粪便泄漏并防止MASD。我们的具体目标 是为了1）优化产品设计以实现可制造性和临床受益; 2）验证产品设计， 生物相容性;以及3）进行临床试验，将该装置与传统的粘性造口术袋进行比较 明尼苏达州圣保罗的健康伙伴研究所和地区医院。成功执行我们的 具体目标将确定器械的安全性和有效性，并确保器械的可制造性 和生物相容性。人类健康益处是改善造口术患者结果的新护理标准， 缩短住院时间，减少再次入院，并减轻医院重大财务风险。

Project Summary/Abstract Over 100,000 patients of all ages undergo ostomy surgery in the United States (US) annually due to a variety of pathophysiologic conditions including colorectal cancer, inflammatory bowel disease (Crohn’s disease and ulcerative colitis), bowel obstruction, diverticulitis, and many other medical conditions. Ostomy surgery may also be necessary in cases of severe abdominal or pelvic trauma resulting from accidents or from injuries sustained during military service. A life-saving procedure, ostomy surgery allows bodily waste to pass through a surgically created opening called a stoma on the abdomen into a prosthetic known as a ‘pouch’ or ‘ostomy bag’ on the outside of the body. Patients are discharged from the hospital within days of ostomy creation and expected to heal at home using disposable ostomy pouches attached to the skin around their stoma. Unfortunately, current pouch designs offer little therapeutic benefit for post-surgery edema (swelling) and may not maintain a tight seal, allowing leakage of intestinal fluid and waste. Resulting stoma complications include mucocutaneous (skin/stoma) separation, stoma retraction, and moisture-associated skin damage. Up to 70% of ostomy patients endure these complications, with 29% of these patients requiring hospital readmissions at an additional cost of $78,000 per patient. Furthermore, risks for complications are higher for high body mass index (BMI) patients. Given the rise in clinical conditions requiring ostomy surgery, the increased BMI of the US population, and the current reimbursement landscape that penalizes the healthcare system for readmissions, an improved post- surgical incision management device to prevent ostomy complications is urgently needed. In this SBIR Direct Phase II, Fistula Solution will develop a novel post-surgical ostomy incision management device designed to prevent complications, form a tight seal, and protect the new stoma. This device stabilizes the tissue around the stoma to reduce edema and tension on sutures, along with holding the skin/stoma junction together to facilitate healing. In addition, the device creates a secure seal to stop stool leaks and prevent MASD. Our specific aims are to 1) optimize product design for manufacturability and clinical benefits; 2) verify product design and biocompatibility; and 3) conduct a clinical trial comparing the device to conventional adhesive ostomy pouches with HealthPartners Institute and Regions Hospital in St. Paul, Minnesota. The successful execution of our specific aims will establish device safety and efficacy and ensure the device is designed for manufacturability and biocompatibility. The human health benefit is a new standard of care to improve ostomy patient outcomes, shorten hospital stays, reduce readmissions to hospital, and mitigate a major financial exposure for hospitals.